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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K140940
Device Name PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
Applicant
Canadian Technical Tape, Ltd.
125 Highpower Rd.
Rochester,  NY  14623
Applicant Contact GARY SOCOLA
Correspondent
Canadian Technical Tape, Ltd.
125 Highpower Rd.
Rochester,  NY  14623
Correspondent Contact GARY SOCOLA
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received04/14/2014
Decision Date 10/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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